U.S. patent application number 14/100468 was filed with the patent office on 2014-04-10 for fenestration through foreign material.
This patent application is currently assigned to Baylis Medical Company Inc.. The applicant listed for this patent is Baylis Medical Company Inc.. Invention is credited to Youssef Biadillah, Gareth Davies, Amanda Hartley, Taras Juzkiw, Naheed Visram.
Application Number | 20140100560 14/100468 |
Document ID | / |
Family ID | 45594649 |
Filed Date | 2014-04-10 |
United States Patent
Application |
20140100560 |
Kind Code |
A1 |
Biadillah; Youssef ; et
al. |
April 10, 2014 |
Fenestration through foreign material
Abstract
Described herein is a method for creating a channel through a
foreign material located in a body of a patient. The foreign
material defines a material first surface and a substantially
opposed material second surface and the channel extends through the
foreign material between the material first and second surfaces.
The method uses an apparatus including an electrode, and includes
the steps of: positioning the electrode substantially adjacent to
the material first surface; energizing the electrode with a
radiofrequency current; and using the electrode energized with the
radiofrequency current to deliver energy into the foreign material
to create the channel. In some embodiments, the patient's body
includes a heart defining a septum, the septum defines an aperture
extending there-through and the foreign material extends across the
aperture to cover the aperture.
Inventors: |
Biadillah; Youssef;
(Lausanne, CH) ; Hartley; Amanda; (Caledon,
CA) ; Davies; Gareth; (Toronto, CA) ; Visram;
Naheed; (Epsom, GB) ; Juzkiw; Taras;
(Mississauga, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Baylis Medical Company Inc. |
Mississauga |
|
CA |
|
|
Assignee: |
Baylis Medical Company Inc.
Mississauga
CA
|
Family ID: |
45594649 |
Appl. No.: |
14/100468 |
Filed: |
December 9, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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13286041 |
Oct 31, 2011 |
8623005 |
|
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14100468 |
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|
11905448 |
Oct 1, 2007 |
8048071 |
|
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13286041 |
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60827466 |
Sep 29, 2006 |
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61448578 |
Mar 2, 2011 |
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Current U.S.
Class: |
606/33 |
Current CPC
Class: |
A61B 2018/00702
20130101; A61B 2018/00083 20130101; A61B 2018/00898 20130101; A61B
2090/3966 20160201; A61B 8/12 20130101; A61B 18/04 20130101; A61B
2018/00214 20130101; A61B 18/1492 20130101; A61B 2018/00827
20130101; A61B 2018/00875 20130101 |
Class at
Publication: |
606/33 |
International
Class: |
A61B 18/04 20060101
A61B018/04 |
Claims
1. A method for creating a channel through a foreign material
located in a body of a patient, said foreign material defining a
material first surface and a substantially opposed material second
surface, said channel extending through said foreign material
between said material first and second surfaces, said method using
an apparatus including an electrode, said method comprising:
positioning said electrode substantially adjacent to said material
first surface; energizing said electrode with a radiofrequency
current; and using said electrode energized with said
radiofrequency current to deliver energy into said foreign material
to create said channel; wherein said body includes a heart defining
a septum, said septum comprising an aperture extending
there-through and wherein said foreign material extends across the
aperture to cover the aperture.
2. The method of claim 1, wherein said foreign material is included
in a septal patch that covers the aperture.
3. The method of claim 2, wherein the septal patch extends in a
plane outside of the septum.
4. The method of claim 2, wherein the septal patch extends inside
the aperture.
5. The method of claim 1, wherein said septum comprises an atrial
septum.
6. The method of claim 1, wherein said septum comprises a
ventricular septum.
7. The method of claim 1, wherein said foreign material includes a
material selected from the group consisting of polyethylene
terephthalate (PET), a cotton, a polyester material and fabrics
thereof.
8. The method of claim 7, wherein said foreign material includes a
synthetic material.
9. The method of claim 8, wherein said synthetic material comprises
a polyester material.
10. The method of claim 1, wherein thermal energy is transferred
from said electrode upon said electrode being energized with said
radiofrequency current to substantially melt said foreign material
adjacent said electrode, thereby creating a channel through said
foreign material, wherein said electrode is heated to a temperature
that is substantially larger than a melting temperature of said
foreign material.
11. A method of gaining access into a left side of a heart, the
heart having a septum defining an aperture, wherein foreign
material extends across the aperture, said method using an
apparatus including an electrode, said method comprising:
positioning said electrode substantially adjacent to said foreign
material; and creating a channel within said foreign material using
said electrode energized with said radiofrequency current to
deliver energy into said foreign material to allow the apparatus to
be advanced through the channel thereby crossing the septum to be
positioned into the left side of the heart.
12. The method of claim 11, wherein the step of positioning said
electrode further comprises gaining access into the heart via an
inferior vena cava.
13. The method of claim 11, wherein the step of positioning said
electrode further comprises gaining access into the heart via a
superior vena cava.
14. A method for creating a channel through a foreign material
located in a body of a patient, said foreign material defining a
material first surface and a substantially opposed material second
surface, said channel extending through said foreign material
between said material first and second surfaces, said method using
an apparatus including an electrode, said method comprising:
positioning said electrode substantially adjacent to said material
first surface; energizing said electrode with a radiofrequency
current; using said electrode energized with said radiofrequency
current to deliver energy into said foreign material to create said
channel; assessing a composition of a material in contact with said
apparatus; and upon determining that said electrode is positioned
adjacent a metallic structure, repositioning the apparatus away
from said metallic structure.
15. The method of claim 14, wherein the steps of assessing and
repositioning the apparatus comprise: measuring an impedance of the
material in contact with said apparatus; determining if the
measured impedance indicates that said apparatus is in contact with
a metallic structure; and repositioning the apparatus upon
determining that said apparatus is in contact with a metallic
structure, while repeating the steps of measuring and determining
until an impedance is recorded indicating that said apparatus is
positioned away from said metallic structure.
16. The method of claim 14, wherein the step of assessing the
composition comprises obtaining tactile feedback.
17. The method of claim 14, wherein the step of assessing the
composition comprises measuring one or more parameters
substantially while delivering energy.
18. The method of claim 15, wherein the impedance is measured
substantially continuously during energy delivery.
19. The method of claim 15, wherein the impedance is measured at
pre-determined intervals during energy delivery.
20. The method of claim 15, wherein the delivery of energy is
changed based on a change in the measured impedance.
21. The method of claim 15, wherein the delivery of energy using
said electrode is stopped prior to repositioning the apparatus.
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 13/286,041, filed on 31 Oct. 2011, which is a
continuation-in-part of U.S. patent application Ser. No.
11/905,448, filed on Oct. 1, 2007, now U.S. Pat. No. 8,048,071,
which claims the benefit of U.S. provisional patent application
Ser. No. 60/827,466 filed on 29 Sep. 2006. U.S. patent application
Ser. No. 13/286,041 further claims the benefit of U.S. provisional
application No. 61/448,578, filed on Mar. 2, 2011. All of these US
patent applications and provisional patent applications are hereby
incorporated by reference in their entirety.
FIELD OF THE INVENTION
[0002] The present invention relates generally to methods and
devices usable to deliver energy within the body of a patient. More
specifically, the present invention is concerned with a method for
creating a channel through foreign material.
SUMMARY OF THE INVENTION
[0003] In contrast to the commonly understood mechanisms of
radiofrequency perforation, it has been unexpectedly found that, as
described further herein below, a radiofrequency-based apparatus is
usable to create channels through foreign materials which may be,
for example, substantially synthetic materials. An embodiment of a
proposed method of a present invention is used to create a channel
within foreign material that extends across an aperture defined by
the septum of the heart of a patient.
[0004] In one broad aspect, embodiments of the present invention
provide a method for creating a channel through a foreign material
located in a body of a patient, said foreign material defining a
material first surface and a substantially opposed material second
surface, said channel extending through said foreign material
between said material first and second surfaces, said method using
an apparatus including an electrode, said method comprising:
positioning said electrode substantially adjacent to said material
first surface; energizing said electrode with a radiofrequency
current; and using said electrode energized with said
radiofrequency current to deliver energy into said foreign material
to create said channel; wherein said body includes a heart defining
a septum, said septum comprising an aperture extending
there-through and wherein said foreign material extends across the
aperture to cover the aperture.
[0005] As feature of this broad aspect, the foreign material is
included in a septal patch that covers the aperture. As an example
of this feature, the septal patch extends in a plane outside of the
septum. As another example of this feature, the septal patch
extends inside the aperture.
[0006] As another feature of this broad aspect, the septum
comprises an atrial septum. As an alternative feature of this broad
aspect, the septum comprises a ventricular septum.
[0007] As still another feature of this broad aspect said foreign
material includes a material selected from the group consisting of
polyethylene terephthalate (PET), a cotton, a polyester material
and fabrics thereof. As an example of this feature, said foreign
material includes a synthetic material. In some embodiments the
synthetic material comprises a polyester material.
[0008] As another feature of this broad aspect thermal energy is
transferred from said electrode upon said electrode being energized
with said radiofrequency current to substantially melt said foreign
material adjacent said electrode, thereby creating a channel
through said foreign material, wherein said electrode is heated to
a temperature that is substantially larger than a melting
temperature of said foreign material.
[0009] In accordance with another broad aspect, some embodiments of
the present invention provide a method of gaining access into a
left side of a heart, the heart having a septum defining an
aperture, wherein foreign material extends across the aperture,
said method using an apparatus including an electrode, said method
comprising: positioning said electrode substantially adjacent to
said foreign material; and creating a channel within said foreign
material using said electrode energized with said radiofrequency
current to deliver energy into said foreign material to allow the
apparatus to be advanced through the channel thereby crossing the
septum to be positioned into the left side of the heart.
[0010] As a feature of this broad aspect, the step of positioning
said electrode further comprises gaining access into the heart via
an inferior vena cava.
[0011] As another feature of this broad aspect, the step of
positioning said electrode further comprises gaining access into
the heart via a superior vena cava.
[0012] In another broad aspect embodiments of the present invention
provide a method for creating a channel through a foreign material
located in a body of a patient, said foreign material defining a
material first surface and a substantially opposed material second
surface, said channel extending through said foreign material
between said material first and second surfaces, said method using
an apparatus including an electrode, said method comprising:
positioning said electrode substantially adjacent to said material
first surface; energizing said electrode with a radiofrequency
current; using said electrode energized with said radiofrequency
current to deliver energy into said foreign material to create said
channel; assessing a composition of a material in contact with said
apparatus; and, upon determining that said electrode is positioned
adjacent a metallic structure, repositioning the apparatus away
from said metallic structure.
[0013] As a feature of this broad aspect the step of assessing the
composition comprises obtaining tactile feedback.
[0014] As another feature of this broad aspect of this feature the
step of assessing the composition comprises measuring one or more
parameters substantially while delivering energy.
[0015] As still another feature of this broad aspect, the steps of
assessing and repositioning the apparatus comprise: measuring an
impedance of the material in contact with said apparatus;
determining if the measured impedance indicates that said apparatus
is in contact with a metallic structure; and repositioning the
apparatus upon determining that said apparatus is in contact with a
metallic structure while repeating the steps of measuring and
determining, until an impedance is recorded indicating said
apparatus is positioned away from said metallic structure.
[0016] As an example of this feature, the impedance is measured
substantially continuously during energy delivery.
[0017] As another example of this feature, the impedance is
measured at pre-determined intervals during energy delivery.
[0018] As still another example of this feature, the delivery of
energy is changed based on a change in the measured impedance.
[0019] As a further example of this feature, the delivery of energy
is stopped prior to repositioning the apparatus.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] In the appended drawings:
[0021] FIG. 1A, in a perspective view, illustrates an apparatus for
creating a channel through a foreign material in accordance with an
embodiment of the present invention;
[0022] FIG. 1B, in a front cross-sectional view taken along the
line 1B-1B of FIG. 1A, illustrates the apparatus of FIG. 1A;
[0023] FIG. 2, in a partial perspective view, illustrates a distal
end region of the apparatus of FIG. 1A;
[0024] FIG. 3A, in a partial perspective view, illustrates an
embodiment of a handle usable with the apparatus illustrated in
FIGS. 1A to 2;
[0025] FIG. 3B, in a side cross-sectional view, illustrates the
handle of FIG. 3A;
[0026] FIGS. 3C and 3D, in perspective views, illustrate an
embodiment of a securing component usable with the handle shown in
FIGS. 3A and 3B;
[0027] FIG. 4, in a flow chart, illustrates a method for creating a
channel in a foreign material in accordance with an embodiment of
the present invention;
[0028] FIGS. 5A and 5B, in schematic views, illustrate a method for
creating a channel in a septal patch extending across an aperture
formed in the heart of a patient in accordance with an embodiment
of the present invention;
[0029] FIGS. 6A and 6B, in schematic views, illustrate a method for
creating a channel in a stent graft extending across an ostium of a
renal artery of a patient in accordance with an embodiment of the
present invention;
[0030] FIGS. 7A and 7B, in schematic views, illustrate a method for
creating a channel in a stent graft extending across an ostium of a
renal artery of a patient in accordance with an alternative
embodiment of the present invention;
[0031] FIGS. 8A and 8B, in schematic views illustrate a method for
creating a channel in a stent graft extending across an ostium of a
left Subclavian Artery (LSA) of a patient in accordance with an
alternative embodiment of the present invention;
[0032] FIG. 8C is a right anterior oblique view illustrating a
method for creating a channel in a stent graft extending across an
ostium of a left Subclavian Artery (LSA) of a patient in accordance
with an alternative embodiment of the present invention;
[0033] FIG. 8D, in schematic view illustrates a method for creating
a channel in a stent graft extending across an ostium of a left
Subclavian Artery (LSA) of a patient in accordance with an
alternative embodiment of the present invention;
[0034] FIGS. 9A and 9B, in schematic view illustrates a method for
creating a channel in a stent graft extending across an ostium of a
left Subclavian Artery (LSA) of a patient in accordance with an
alternative embodiment of the present invention; and
[0035] FIG. 10 is a flow chart showing steps of a method in
accordance with an embodiment of the present invention.
DETAILED DESCRIPTION
[0036] Generally speaking, the proposed method is performed for
creating a channel through foreign material located in a body of a
patient. The foreign material defines a material first surface and
a substantially opposed material second surface and the channel
extends through the foreign material between the material first and
second surfaces. Typically, the method uses an apparatus including
a substantially elongated member defining a proximal end region and
a substantially longitudinally opposed distal end region, the
substantially elongated member including an electrode located about
the distal end region.
[0037] The method includes positioning the electrode substantially
adjacent to the material first surface; energizing the electrode
with a radiofrequency current; and using the electrode energized
with the radiofrequency current to deliver energy into the foreign
material to create the channel.
[0038] For example, the method is usable for restoring blood flow
to a blood vessel of a body of a human or animal, the blood vessel
being occluded by a foreign material. In this case, the channel is
created through the foreign material.
[0039] As a feature of the aforementioned aspects, in some
embodiments of the invention, the apparatus has a substantially
atraumatic distal end, thus reducing the risk of unintentional
perforation of a body vessel or other tissues. Also, the use of
energy in creating the channel allows for the creation of channels
in foreign materials through which creation of such channels is
difficult, if not impossible, to perform using mechanical force. In
some embodiments, the method is performed using relatively small
apparatuses, for example apparatuses having a relatively small
diameter, which are therefore relatively easily introduced into
relatively small vessels.
[0040] With specific reference now to the drawings in detail, it is
stressed that the particulars shown are by way of example and for
purposes of illustrative discussion of embodiments of the present
invention only, and that many alternative embodiments of the
invention are within the scope of the appended claims.
[0041] For the purposes of this description, the term `proximal`
indicates next to or nearer to the user, and the term `distal`
indicates further away from the user, when the apparatus is in
use.
APPARATUS
Structure
[0042] As illustrated in FIG. 1, one embodiment of an apparatus 100
according to the present invention includes a substantially
elongated member 102 defining a distal end region 104 and a
proximal end region 106. The distal end region 104 includes a
distal tip 108 and an electrode 110 located about the distal end
region 104. The electrode 110 is usable as a radiofrequency energy
delivery component. In the embodiment shown in FIG. 1, the
apparatus 100 further comprises an actuator 112 for directing at
least a portion of the distal end region 104 in a desired
direction.
[0043] The elongated member 102 may be electrically conductive and
may be operable to conduct electrical energy to the distal tip 108,
and more specifically to the electrode 110. In such embodiments,
the elongated member 102 is also known as as a core wire. In the
illustrated embodiments, the elongated member 102 is at least
partially covered with an insulating material 114 for substantially
preventing conduction of electrical energy to surrounding bodily
tissue. In accordance with these embodiments, the insulating
material 114 may be made of any of a variety of electrically
insulating materials and may have any suitable thickness, provided
that the elongated member 102 is at least partially electrically
insulated. In one particular embodiment, the insulating material
114 is at least about 0.1 mm thick. The elongated member 102 may
comprise a wire that is narrow enough to be navigated through a
blood vessel. In some specific embodiments, the elongated member
102 measures about 0.2 mm to about 1.0 mm in diameter.
[0044] In alternative embodiments, the insulating material 114 is
discontinuous at one or more locations along the elongated member
102. For example, in one such embodiment, a number of
discontinuities in the insulating material 114, along the length of
the elongated member 102, create a `banded` appearance, wherein
insulated regions are interleaved between electrically exposed and
conductive regions. In another embodiment, a region of the
insulating material 114 does not completely circumscribe the
elongated member 102. For example, insulating material 114 may
traverse approximately 180 degrees of the circumference of the
elongated member 102, leaving the remaining area electrically
exposed. Any shape or pattern of discontinuities may be present and
the invention is not intended to be limited in this regard.
Discontinuities in the insulating material 114 may affect the
distribution of energy, for example current density, around the
elongated member 102 when the elongated member 102 is used to
deliver energy. Embodiments of the present invention comprising
such discontinuities may be suitable for specific applications, for
example, when it is desirable to deliver energy along a portion of
the length of the elongated member 102 or to focus the delivery of
energy to a particular location or target site. In some
embodiments, discontinuities in the insulating material 114
correspond, at least in part, to discontinuities in the structure
of the elongated member 102. For example, in one specific
embodiment, notches, described in greater detail below, are present
in the elongated member 102, the thickness of the insulating
material 114 being reduced in the vicinity of the notches.
[0045] In some embodiments, at least a portion of the proximal end
region 106 of the elongated member 102 is electrically exposed,
such that the elongated member 102 may be electrically coupled to
an energy source, for example using an electrical connector.
[0046] In alternative embodiments, the elongated member 102 is made
out of an electrically insulating material. In such embodiments,
the insulating material 114 is typically not required. For example,
in some embodiments, the elongated member 102 is made out of nylon
(e.g. Pebax), polyetheretherketone (PEEK), or polypropylene, and at
least one electrode 110 is attached to the distal tip 108, the
electrode 110 being electrically couplable to an energy source. In
one particular embodiment, the electrode 110 is electrically
coupled to the actuator 112, which itself may be made of an
electrically conductive material and which may be capable of being
electrically coupled to an energy source. Alternatively, one or
more electrodes 110 are attached to the elongated member 102,
rather than to the actuator 112.
[0047] In some embodiments, at least a portion of the distal end
region 104 is structured to prevent unwanted damage to a body
vasculature of a patient when the apparatus 100 is inserted
therethrough. For example, as shown in FIG. 2, the distal tip 108
may have a substantially atraumatic shape, for example having a
blunt or rounded edge, for preventing such damage as the apparatus
100 is maneuvered through the body vasculature. In other
embodiments, the distal tip 108 may be substantially semispherical,
hemispherical, spherical or flattened, or may have any other shape
that is unlikely to damage tissues upon contact. Alternatively or
in addition, in some embodiments, at least a portion of the distal
end region 104 of the elongated member 102 has a reduced rigidity
relatively to the proximal end region 106. The reduced rigidity may
serve to further decrease the ability of the elongated member 102
to puncture tissue, for example the tissue of a vessel wall, with
the application of mechanical force. This reduced rigidity may be
achieved by, for example, by the inclusion or substitution of a
different material in the manufacture of the elongated member 102,
by reducing the amount of material present in at least a portion of
the distal end region 104, or by reducing the diameter of the
actuator 112. Material may be removed, for example, by using a
latticework or other discontinuous structural framework, or
alternatively by thinning the wall of a portion of the elongated
member 102.
[0048] In some embodiments, as seen in FIG. 1B, the elongated
member 102 defines a lumen 116, as will be described further herein
below, and the wall thickness of the elongated member 102 tapers in
the portion of distal end region 104 approaching the distal tip
108. For example, the elongated member 102 may taper from inside to
outside, thereby maintaining a consistent outer diameter and having
a changing inner diameter. Alternatively, the elongated member 102
may taper from outside to inside, thereby maintaining a consistent
inner diameter and having a changing outer diameter, or from both
the inside and the outside thereby having the outer diameter
decrease and the inner diameter increase.
[0049] As has been mentioned above, the apparatus 100, as shown in
the illustrated embodiments, includes an electrode 110 located
about the distal end region 104. The electrode 110 may be integral
with one or both of the elongated member 102 and the actuator 112
or may be otherwise attached to the distal tip 108. For example,
the distal tip 108 may be covered with an electrically conductive
cap, the cap thus forming the electrode 110. In embodiments wherein
the electrode 110 is not integral with one or both of the elongated
member 102 and actuator 112, the electrode 110 may be otherwise
electrically coupled to one or both of the elongated member 102 and
actuator 112 or to another wire operable to electrically couple
electrode 110 to an energy source. For example, in one embodiment,
the electrode 110 is integral with the actuator 112 and may be
associated with the distal tip 108 by being passed through the
elongated member 102. Alternatively, when the apparatus 100
comprises a core wire, as described hereinabove, the electrode 110
may be integral with the core wire.
[0050] The electrode 110 may be larger or smaller, or may have the
same diameter, as the distal tip 108. In some embodiments, the
electrode 110 is sized to be operable to generate sufficient heat
to create the channel in the foreign material, when energy is
supplied to the electrode at a sufficient power level. In the
context of the present invention, the term foreign material
encompasses any material foreign to the body being treated
including synthetic materials. In one specific embodiment, the
electrode may measure from about 0.40 mm to about 0.43 mm in
diameter and from about 1.2 mm to about 1.5 mm in length.
[0051] In the embodiment shown in FIG. 1B, as has been mentioned
above, the elongated member 102 defines a lumen 116 extending at
least partially therethrough. FIG. 1B shows one embodiment of a
centrally located substantially circular lumen 116 defined by the
elongated member 102. In alternative embodiments, the lumen 116 has
any other suitable alternative shape and size and may be
eccentrically located through the elongated member 102. In other
embodiments that do not comprise the lumen 116, the elongated
member 102 is a substantially solid structure. The lumen 116 may be
sized to receive the actuator 112 therein, as shown in FIG. 1. For
example, in some embodiments, the lumen 116 is large enough to
receive the actuator 112, but is not large enough to accommodate
other wires, sensors, or the passage of fluid. In further
embodiments, the lumen 116 is sized to receive the actuator 112
along with one or more wires but is still not be large enough to
accommodate fluid flow. In one specific embodiment, the lumen 116
measures about 0.1 mm to about 1.0 mm in diameter. The flexibility
of the elongated member 102 may be dependent, in part, on the wall
thickness of the elongated member 102, between an inner diameter
defined by the lumen 116 and an outer diameter. In one particular
embodiment, the elongated member 102 has a wall thickness measuring
about 0.01 mm to about 0.2 mm. The flexibility of the elongated
member 102 is also dependant on the outer diameter of the elongated
member 102. In some embodiments, the elongated member 102 has a
beam strength of at least 0.001 lbf as measured by the ASTM E855-90
3-point bent test.
[0052] In the embodiment illustrated in FIGS. 1A, 1B and 2, the
actuator 112 is operable to direct at least a portion of the distal
end region 104 in a desired direction. In one embodiment, the
actuator 112 comprises a single pull-wire disposed within the lumen
116 of the elongated member 102 and attached to at least one point
in the distal end region 104 of the elongated member 102. For
example, the actuator 112 may be attached to the distal end region
104 at or adjacent to the distal tip 108. The actuator 112 may be
relatively thin, in some embodiments, in order to allow the inner
diameter of the elongated member 102 to be reduced, thus
potentially reducing the diameter of the apparatus 100 as a whole.
In one particular embodiment, the actuator 112 measures from about
0.03 mm to about 0.30 mm in diameter.
[0053] The actuator 112 may be attached to the elongated member 102
such that manipulation of the actuator 112 via the application of
mechanical energy to transmit tension along the length of the
actuator 112 may effect a change in the elongated member 102. For
example, in some embodiments, manipulation of the actuator 112 may
cause at least a portion of the elongated member 102 to change
shape. Such a change of shape may involve the adoption of a bent
configuration, wherein, the term "bent" is defined to mean having a
deviation from a straight line; this may take the form of a rigid
bend or a subtler curve, with one or more angles of curvature. In
other embodiments, this change of shape may involve a compression,
or accordion-like collapsing of the elongated member 102, wherein
one or more sections of the elongated member 102 fold or bend
backwards. Such an effect may cause the position of the distal tip
108 to change, without necessarily inducing any deviation of the
distal tip 108 away from the longitudinal axis of the distal end
region 104 (i.e. the distal tip 108 may still point in its original
direction).
[0054] In other embodiments of the present invention, the apparatus
100 may comprise other means for directing at least a portion of
the distal end region 104 in a desired direction. For example, the
apparatus 100 may comprise one or more electro-magnetic,
piezoelectric or hydraulic mechanisms for changing the shape of the
elongated member 102. In one such embodiment, the apparatus 100 may
comprise at least one magnetically responsive element, which may
assist in guiding the apparatus 100 to a desired direction upon the
application of a magnetic field.
[0055] In some embodiments, the apparatus 100 includes a pre-formed
curved section. In such embodiments, the distal tip 108 may be
directed in a desired direction by applying torque to the proximal
end region 106. In such embodiments, an actuator may not be
required.
[0056] With respect now to the embodiment shown in FIG. 2, the
distal end region 104 of the elongated member 102 may contain one
or more notches 200 to aid in a change of shape of the elongated
member 102 when tension is applied through the actuator 112. For
the purposes of this description, the notches 200 may be any
regions wherein discontinuities are present in the wall of the
elongated member 102. In some embodiments, the notches 200 comprise
scores, cuts, or other discontinuities in either the inner or outer
surface of the wall of the elongated member 102 that do not
completely traverse the circumference of the elongated member 102.
In alternative embodiments, the notches 200 comprise regions
wherein entire sections of the wall of the elongated member 102 are
absent. In one specific example, as shown in FIG. 2, one or more
sections of the wall of the elongated member 102, each section
extending at least 180 degrees around the circumference of the
elongated member 102, are absent, which may result in a toothed or
serrated appearance. Notches 200 are present, for example, along
about 5 mm to about 50 mm of the length of the elongated member
102. The notches 200 may be regularly or irregularly spaced,
identically, similarly or dissimilarly sized, oriented at any angle
with respect to the elongated member 102 and may lie at any
suitable angles along the elongated member 102. The notches 200 may
have abrupt edges or may comprise regions where the thickness of a
wall of the elongated member 102 changes gradually to create a
discontinuity.
[0057] In other embodiments, the notches 200 comprise regions
composed of a material different than that of the surrounding body
of the elongated member 102. For example, in one embodiment, the
elongated member 102 is made primarily of stainless steel while the
notches 200 comprise regions of the elongated member 102 made of a
different material, for example an elastic compound. The notches
200 thus represent discontinuities in the material of the wall of
the elongated member 102, without necessarily changing the profile
or thickness of the elongated member 102.
[0058] The notches 200 may be operable to assist in directing a
change in shape of the elongated member 102 when a force is applied
to the elongated member 102 through an actuator 112. In one such
embodiment as described above, the application of tension to the
actuator 112 applies a force to an attachment point at the distal
tip 108, pulling the attachment point in a proximal direction. As
notches 200 may serve to locally increase the flexibility of the
elongated member 102, the elongated member 102 may change shape to,
for example, bend preferentially in the direction of the notches
200 when tension is applied. Thus, in some embodiments, the notches
200 may be shaped and positioned around the elongated member 102
such that the elongated member 102 will adopt a certain specific
curve or series of curves when tension is applied to the actuator
112.
[0059] In some embodiments of the present invention, and referring
now to FIG. 3A, apparatus 100 includes a handle 300 mechanically
coupled to the proximal end region 106 of the elongated member 102.
The handle 300 may be suitable for grasping and manipulating the
apparatus 100, for example during insertion, positioning or guiding
thereof, and may, in some embodiments, be operable to facilitate a
change in shape of the elongated member 102. Referring to FIG. 3B,
in some embodiments, the handle 300 comprises a housing 302, a
first securing component 304 and a second securing component 306.
The handle 300 may further comprise a means for connecting an
energy source to one or more of the elongated member 102, the
actuator 112 and any other electrical conductor operable to deliver
energy to the electrode 110. For example, the handle 300 may
comprise an electrical connector for connecting to an energy
source. In such embodiments, the electrical connector may be
coupled to handle the 300 via an electrical cable. Alternatively,
as shown in FIG. 3B, the actuator 112 may extend from a proximal
end of the handle 300 and may be operable to be electrically
coupled to an energy source.
[0060] The first securing component 304 may be operable to secure
the handle 300 to the elongated member 102, while the second
securing component 306 is operable to secure the handle to the
actuator 112. In the embodiment shown in FIGS. 3B to 3D, the second
securing component 306 comprises a clamping apparatus operable to
securely engage the actuator 112. Actuation of the handle 300 via,
for example, a button 310, may effect a change in the relative
positions of the first securing component 304 and the second
securing component 306, thus causing the elongated member 102
and/or actuator 112 to move with respect to one another. However,
actuation of the handle 300 may be achieved using any means for
displacing a wire or similar component, including but not limited
to one or more of a button, a knob and a switch. Actuation of the
handle 300 may involve the use of mechanical (including linear,
rotational and other forces) and/or electrical energy and may be
accomplished remotely. In some embodiments, the handle 300 includes
a ratcheting mechanism to maintain tension in the actuator 112, for
example by maintaining the position of one or more of the first
securing component 304 and the second securing component 306
following actuation of the handle 300. In some embodiments, the
handle 300 may be removable. For example, in one such embodiment,
the first and second securing components 304 and 306 are each
detachable from the elongated member 102 and the actuator 112,
respectively. In such embodiments, the handle 300 may further be
re-attachable after having been removed. Furthermore, in such
embodiments, the handle 300 may additionally comprise one or more
visual markers and/or one or more locks or other fastening
mechanisms to aid in the positioning and attachment of the first
securing component and the second securing component 306
respectively to the elongated member 102 and the actuator 112. Such
markers and/or locks may be useful to orient the direction of
bending of the elongated member 102 with respect to the handle 300,
and to calibrate the actuator 112 to the amount of tension already
present in the actuating mechanism. In embodiments comprising an
actuator 112 that utilizes means other than tension to direct
apparatus 100 in a desired direction, the handle 300 may be
operable to manipulate the actuator to effect the desired change in
direction.
[0061] In accordance with embodiments of the present invention, any
portion of the elongated member 102, the actuator 112, the notches
200, the electrode 110 or the insulating material 114 may comprise
one or more markers. Such markers may include visual markers,
tactile markers, radiopaque markers, radiolucent markers, or any
other markers used to aid in the visualization, localization,
navigation, insertion, or detection of apparatus 100. Markers may
be externally applied to a component, and may be of a variety of
shapes and structures; they may be raised from the surface of a
component or may conform to the surface of the component; and they
may be internal to a component. In some embodiments, components may
be manufactured in whole or in part from materials that provide a
visual or tactile distinction, thus acting themselves as markers.
For example, in one embodiment, the insulating material 114 is
manufactured from a radiopaque insulating material or from a
material comprising radiopaque fillers. In another embodiment, one
or more of the elongated member 102, the distal tip 108, the
electrode 110 and the actuator 112 are plated with a radiopaque
material, such as platinum or tungsten. In yet another embodiment,
a radiopaque marker, such as a band, is welded or otherwise
attached to, for example, the distal tip 108 or the electrode
110.
[0062] In some embodiments, as mentioned hereinabove, any or all of
the lumen 116, the actuator 112 and the notches 200 may not be
present in the apparatus, in order, for example, to simplify the
process of manufacturing the apparatus 100 and make it more
cost-effective. In addition, in such embodiments, the apparatus 100
may have substantially similar mechanical properties when compared
to a standard mechanical guide-wire.
[0063] In some embodiments of the present invention, the apparatus
100 further comprises one or more means for guiding the apparatus
100 within the body of the patient. For example, in one particular
embodiment, the apparatus 100 further comprises an ultrasound
transducer (not shown in the drawings) associated with the distal
end region 104. The ultrasound transducer (not shown in the
drawings) may be operable as an intra-vascular ultrasound (IVUS)
device, which may assist in determining the position of the
apparatus 100 within a blood vessel, for example. In such an
embodiment, the ultrasound transducer (not shown in the drawings)
may be electrically connected to an ultrasound generator, for
example via one or both of the elongated member 102 and the
actuator 112. In another specific embodiment, the apparatus 100
further comprises at least one optical fiber (not shown in the
drawings) which may be optically coupled to an optical coherence
reflectometry (OCR) system (not shown in the drawings), which may
also assist in determining the position of the apparatus 100 within
a blood vessel, for example. Another example of a suitable device
or apparatus is described in application Ser. No. 12/926,292, which
is incorporated herein by reference in its entirety.
Materials
[0064] In embodiments wherein the elongated member 102 takes the
form or includes an electrically conductive core wire, as described
hereinabove, it may be made of a biocompatible metal or metal
alloy, for example, including, but not limited to, stainless steel
or nitinol. The actuator 112 may be conductive, and may, in some
embodiments, have a high tensile strength, thus being able to
tolerate the application of sufficient force to cause a change in
shape of the elongated member 102, when a force is applied to the
actuator 112. An example of a material that is suitable for the
actuator 112 is nitinol. The insulating material 114 may be
composed from any material capable of providing electrical
insulation, including, in some embodiments, Parylene or
polytetrofluoroethylene (PTFE). The insulating material 114 may be
applied to the elongated member 102 by a variety of methods
including, but not limited to: being overlain onto the elongated
member 102 and shrunk by the application of heat, being extruded
over the elongated member 102, and being sprayed or painted onto
the elongated member 102 in liquid form. Suitable materials for
radiopaque markers or components include, but are not limited to,
high-density metals such as platinum, iridium, gold, silver,
tantalum, and tungsten or their alloys, or radiopaque polymeric
compounds. Although the above materials are suggested as being
suitable options for the manufacture of components of the present
invention, the list is by no means meant to be limiting, and any
other components with suitable properties may be used.
METHOD
[0065] In some embodiments, the apparatus 100 is usable to create a
channel in a foreign material located the body of a patient (not
shown in the drawings). This channel may be created, in some
embodiments, at least partially by the delivery of energy using the
electrode 110. More specifically, the electrode 110 is energized
with a radiofrequency current and the electrode 110 is then used to
deliver energy into the foreign material to create the channel. In
some embodiments, the energy delivered in the foreign material is
thermal energy.
[0066] Without being limited to a particular theory of operation,
it is hypothesized that, in some embodiments, the proposed method
is performed when the electrode 110, which is energized with a
radiofrequency current, heats up to a predetermined temperature.
For example, the predetermined temperature may be substantially
larger than a melting temperature of the foreign material. Then,
thermal energy is transferred from the electrode 110 to the foreign
material to substantially melt the foreign material adjacent to the
electrode 110, thereby creating a channel through the foreign
material. In other embodiments, it is hypothesized that water may
be absorbed by the foreign material, and radiofrequency energy that
is thereafter delivered to the foreign material may cause
vaporization of the water adjacent to the electrode 110, thereby
creating a channel through the foreign material.
[0067] In some embodiments, heating of the electrode 110 is
performed while the electrode 110 is positioned at a predetermined
distance from the foreign material and from biological tissues
adjacent to the foreign material. Positioning the electrode at a
predetermined distance from the foreign material and from the
biological tissues adjacent to the foreign material minimizes risks
of injuring the biological tissues adjacent to the foreign
material. For example, the predetermined distance is such that
thermal energy transfer between the electrode 110 and either or
both of the foreign material and biological tissues adjacent to the
foreign material results in a non-damaging increase in temperature
thereof. As mentioned hereinabove, the use of a radiofrequency
current to heat the electrode 110 helps in minimizing this heat
transfer, and therefore contributes to the practicality of the
proposed method as the predetermined distance is then relatively
small.
[0068] Minimizing injuries to tissues is of paramount importance
when performing interventions in patients. Indeed, injuring a
tissue typically creates stress and inflammatory responses that may
cause irreversible damages to many tissues. In addition, many
patients have a relatively sensitive hypothalamic-pituitary-adrenal
axis (HPA axis) and local stresses to tissues can lead in these
patients to systemic and psychiatric conditions and diseases. In
some embodiments, the proposed method is performed in the heart of
the patient. In these cases, these irreversible damages can lead to
dysfunctions in the contractile and electrical conductivity
properties of the cardiac tissue, which themselves can lead to
life-threatening conditions.
[0069] It is hypothesized that providing the radiofrequency current
to the electrode 110 within the body creates a layer of water vapor
around the electrode 110, which reduces thermal transfer between
the electrode 110 and adjacent structures that are sufficiently
spaced apart therefrom. This helps in ensuring a relatively fast
heating of the electrode 110 and reduce risks of damaging
biological tissues as described hereinabove.
[0070] In such embodiments, the electrode 110 is then moved so as
to be substantially adjacent to the foreign material. As the
electrode has now attained a temperature substantially higher than
the melting temperature of the foreign material, the electrode
effectively melts the foreign material to create a channel
therethrough.
[0071] However, in alternative embodiments of the invention,
positioning of the electrode 110 substantially adjacent to the
foreign material, for example to a first surface of the foreign
material, is performed before energizing the electrode 110.
[0072] Generally speaking, the aforementioned specifics of the
proposed method are typically part of a treatment procedure
comprising the steps of: providing the apparatus 100, or any other
suitable apparatus; inserting at least a portion of the apparatus
100 into the body of the patient, for example by introducing the
distal end region into the body of the patient; positioning the
electrode 110 substantially adjacent to the material first surface;
energizing the electrode 110 with a radiofrequency current; and
using the electrode 110 energized with the radiofrequency current
to deliver energy into the foreign material to create the channel.
Further embodiments may comprise additional steps of, for example,
manipulating an actuator, or otherwise guiding the apparatus 100
through one or more of the body vasculature of the patient and the
channel.
[0073] In accordance with embodiments of the treatment method
aspects of the present invention, the apparatus 100 may be a
component of a system including an energy source (not shown in the
drawings) (such as, for example, the RFP-100 or RFP-200 Baylis
Medical RF Puncture Generators, manufactured by Baylis Medical
Company Inc., Montreal, Canada), and a grounding pad (not shown in
the drawings) or any other return electrode, if operated in a
monopolar mode.
[0074] FIG. 4 illustrates, in a flow-chart form, one embodiment of
a method 400 in accordance with the present invention. This
embodiment comprises: at step 402, preparing a patient and a system
for treatment; at step 404, inserting a portion of the apparatus
100, into the body vasculature of the patient; at step 406,
navigating the apparatus 100 through the body vasculature to a
target site; at step 408, changing a of shape, or otherwise
reorienting the apparatus 100 in order to position the electrode
110, or any other suitable electrode, adjacent at least a portion
of the foreign material; at step 410, confirming or otherwise
assessing the position of the electrode 110; at step 412,
delivering energy via the apparatus 100 to create a channel in the
foreign material; at step 414, advancing the apparatus 100, for
example the distal end region 104 and the electrode 110, through
the channel; at step 416, assessing the position of the electrode
110 or any other portion of the apparatus 100 after it has been
advanced through the channel; and, at step 418, performing an
additional procedure at or around the target site. The reader
skilled in the art will readily appreciate that the patient may be
a human or an animal and that one or more of these steps may not
necessarily be performed in a given procedure or that one or more
of these steps may be performed in a different order, as will be
further clarified hereinbelow.
[0075] In step 402, preparing a patient for treatment may include,
but is not limited to one or more of: visualizing one or more
treatment sites within the body of the patient using fluoroscopy,
x-ray, contrast media, labeled markers such as radioactive
compounds or solutions, using endoscopy procedures, using
ultrasound, using Doppler imaging, or any other visualization
method; characterizing the vascular system of the patient by
measuring blood or serum levels of various compounds; measuring
vascular pressure; and undertaking any other measuring or
monitoring technique that may provide information that may be
useful during any other step of the method. In step 402, preparing
a system for treatment may include, but is not limited to one or
more of: connecting a treatment apparatus, for example the
apparatus 100 as described above, to an energy source; connecting a
grounding pad or other return electrode to the energy source;
placing the grounding pad or return electrode on the body of the
patient; passing the actuator 112 through the elongated member 102
(in some embodiments, the actuator 112 may be permanently threaded
through the elongated member 102, thus obviating this step), if the
apparatus 100 comprises the actuator 112; securing the handle 300
to the actuator 112 and the elongated member 102 (in some
embodiments, the handle 300 may be permanently connected to the
elongated member 102 and the actuator 112, thus obviating this
step); and attaching one or more additional components to the
apparatus 100. As mentioned above, one or more of these steps may
not be performed in a particular procedure, depending on the
apparatus 100 being used and the specific procedure being
performed.
[0076] The step 404 of inserting the apparatus 100 into the body
vasculature of the patient may comprise percutaneously inserting
the apparatus 100 into a blood vessel of the body vasculature
through which the apparatus may be navigated to the target site.
For example, in some embodiments, the apparatus 100 may be inserted
into a femoral artery or vein or a subclavian artery or vein. The
apparatus may be inserted directly into the blood vessel or may be
inserted through a guiding catheter or sheath.
[0077] The step 406 of navigating the apparatus 100 through the
body vasculature to a target site may involve advancing the
apparatus 100 through the body vasculature to the target site. In
some specific embodiments, in which the apparatus is inserted
through a guiding sheath or catheter, the sheath or catheter may
initially be navigated to the target site, for example by initially
inserting a guidewire to the target site and then tracking the
sheath/catheter over the guidewire. Once the sheath/catheter is in
place, the guidewire may be removed and the apparatus 100 may be
inserted through the sheath/catheter. Step 406 may additionally
involve any of a variety of visualization techniques, including
those techniques mentioned above for visualizing one or more
treatment sites within the body of the patient. In one embodiment,
the apparatus 100 may be furnished with one or more radiopaque
markers, which may aid in the visualization of the apparatus
100.
[0078] The step 408 of affecting a change of shape in the apparatus
100 may be required, for example if the step of navigating the
apparatus 100 does not position the apparatus 100 sufficiently
precisely. This step is, in some embodiments, accomplished by
effecting a change of shape in the distal end region 104 of the
elongated member 102, as described hereinabove. In some
embodiments, it may be desirable to approach the foreign material
substantially perpendicularly, for example at an angle of about 80
degrees to about 100 degrees, and step 408 is usable to control
this angle.
[0079] The step 410 of confirming a position of the apparatus 100
may involve visualizing the position of one or more portions of the
apparatus 100 within the body of the patient. For example,
radiopaque markers included in the apparatus 100 may be visualized
using fluoroscopy. Alternatively, or in addition, radiopaque
contrast may be injected, for example through the guiding
sheath/catheter, in order to confirm the position of the apparatus
100. Furthermore, in some embodiments, the apparatus 100 may
include a pressure sensor (not shown in the drawings) operatively
coupled to the distal end region of the apparatus for measuring a
pressure at or around the distal end of the apparatus. In such
embodiments, blood pressure may be reassured in order to confirm
the position of the apparatus.
[0080] The step 412 of delivering energy may include an optional
step of measuring, assessing or sensing the composition of the
foreign material to be penetrated. For example, in one embodiment,
the apparatus 100 may be used as part of an impedance monitor to
determine the impedance of the material to be penetrated. The
impedance value thus measured may then be compared to known
impedance values of various materials in order to determine the
composition of the material to be penetrated. Then, energizing the
electrode 110 is performed, in some embodiments, at least in part,
in a manner depending on the composition of the foreign material.
For example, the electrode 110 may be energized at various power
levels, depending on the nature of the foreign material.
Alternatively, a change in impedance may indicate that the material
in contact with the apparatus has changed. For example, a lower
impedance may indicate that the apparatus is in contact with a
metallic or otherwise conductive portion of a stent or scaffold, as
opposed to the graft material associated with the stent/scaffold.
In such a situation, a user may reposition the apparatus until a
suitable impedance measurement is recorded indicating that the
apparatus is substantially adjacent to the foreign material through
which the channel is to be created.
[0081] Alternatively, tactile feedback may be used to assist in
determining the material in contact with the apparatus. For
example, a user may use tactile feedback to determine whether the
apparatus is in contact with metallic material of a stent/scaffold
or more flexible graft material, through which a channel may be
created. Alternatively, or in addition, imaging techniques (for
example OCR and/or IVUS) may be used to determine the composition
of material in contact with the apparatus 100. As described
hereinabove, the composition of the material to be penetrated may
determine the initial parameters of energy delivery.
[0082] The step 412 of delivering energy via the apparatus 100 to
create a channel in the foreign material comprises, in one
embodiment, delivering electromagnetic energy (for example electric
energy in the radiofrequency (RF) range) to the electrode 110. In
one specific embodiment, the RF current provided may have a
frequency in the range of from about 300 kHz to about 1 MHz, and
more specifically, in very specific embodiments of the invention,
of from about 460 kHz to about 500 kHz, and may be delivered with a
power of at least about 5 W at a voltage of at least about 75 Volts
(peak-to-peak).
[0083] In some embodiments, one or more parameters may be measured
substantially while energy is being delivered and/or the device is
being advanced. For example, impedance may be measured
substantially continuously or at predetermined intervals during
energy delivery and/or advancement of the apparatus and a change in
impedance may lead to a change in energy delivery. In one
particular example, a drop in impedance may indicate that the
apparatus is contacting a metallic portion of a stent/scaffold and
energy delivery may be stopped so that the device may be
repositioned. The change in energy delivery may be automatic or may
be manually performed by the user.
[0084] In some embodiments of the invention, the energy may be
delivered for a predetermined amount of time before stopping the
delivery of the energy. In other embodiments, the intended user may
decide, during the course of the procedure, on the amount of time
during which energy should be delivered. The intended user's
decision may depend, for example, on one or more of tactile
feedback, impedance measurements, pressure measurements,
predetermined information regarding the material being penetrated
(e.g. the thickness of the material) or the preferences of the
intended user. In one example, if a user feels that the device has
penetrated through the foreign material he may stop delivering
energy. In some embodiments, the amount of time during which energy
is delivered is from about 0.1 seconds to about 5 seconds. In a
more specific embodiment of the invention, the amount of time
during which energy is delivered is from about 1 second to about 2
seconds. During these periods of time, the energy may be delivered
continuously or as a pulsed waveform.
[0085] The step 414 of advancing the apparatus through the channel
may comprise applying a longitudinal force to the proximal end
region 106 of the apparatus 100 in order to advance the distal end
region 104 of the apparatus 100 through the channel. Alternatively,
mechanical or magnetic means for advancing the apparatus may be
used. In some embodiments, step 414 occurs at least partially
concurrently with step 412, such that the apparatus is advanced
while energy is being delivered.
[0086] Following step 414, the position of the apparatus 100, after
passing through the channel, may be confirmed at step 416. Step 416
may be performed in substantially the same manner as step 410,
described hereinabove.
[0087] The step 418 of performing another treatment procedure may
involve, in some embodiments, one or more of: introducing a balloon
catheter, a dilator or other means for dilation of the channel, to
the target site, for example overtop of or through the apparatus
100; introducing a stent or other supporting structure to the
target site, for example overtop of or through the apparatus 100;
delivering a pharmaceutical compound to the target site; delivering
energy to create a lesion or coagulate tissue or fluid in the
vicinity of the target site; introducing embolic coils; placing an
IVUS or OCR probe for visualization; or adding or removing any
other material to or from the site. In addition, this step may
further comprise removal and possible re-attachment of the handle
300 of the apparatus 100, in order to allow for the introduction of
another device to the treatment site. As mentioned hereinabove, in
alternative embodiments of the invention, the electrode 110 is
energized after having been positioned adjacent to the foreign
material.
[0088] Embodiments of the treatment procedure described above may
be particularly useful to create a channel through material of a
stent graft occluding one or more vessels of a patient's body.
Several examples of such applications are noted hereinbelow. While
these examples have been described in specific detail, one of skill
in the art will appreciate that embodiments of the present
invention may be utilized in various other procedures and
applications.
EXAMPLES
Example 1
[0089] In a first example, an embodiment of a proposed method is
used to create a channel 512, seen in FIG. 5B, within a septal
patch 510 made of foreign material, the septal patch 510 defining a
material first surface 514 and a substantially opposed material
second surface 516. The channel 512 extends between the material
first and second surfaces 514 and 516. The septal patch 510 extends
across an aperture 518 defined by the septum 520 of the heart 500
of the patient, for example an atrial septum or a ventricular
septum. For example, the septal patch 510 covers the aperture and
extends in a plane outside of the septum 520. In other examples,
the septal patch 510 extends inside the aperture 518. Some of these
procedures may involve patients that have had a septal defect
repaired with the septal patch 510. In some cases, such patients
may suffer from one or more conditions which require access to the
left side of the heart for treatment to be performed. In such
situations, access to the left side of the heart may be gained by
creating the channel 512 in the septal patch 510. In such
embodiments, the septal patch 510 may be made of a foreign material
selected from the group consisting of polyethylene terephthalate
(PET, for example Dacron.RTM.), cotton, a polyester material and
fabrics thereof.
[0090] With reference to FIG. 5A, the apparatus 100 is inserted
through the inferior vena cava 502 into the right atrium 506 of the
heart 500. In alternative embodiments, access to the right atrium
may be achieved via the superior vena cava 504 as described, for
example, in U.S. patent application Ser. No. 11/265,304 (Filed on
Nov. 3, 2005), now U.S. Pat. No. 7,947,040, which is incorporated
herein by reference in its entirety. FIG. 5A shows the apparatus
100 positioned in the right atrium 506 with the electrode 110
located substantially adjacent the material first surface 514. FIG.
5B shows the apparatus 100 positioned in the left atrium 508 after
being advanced through the channel 512. In this particular
embodiment, radiofrequency energy may be delivered, for example, at
about 5 W for a period of less than about 5 seconds.
[0091] In a further example application, an embodiment of a method
according to the present invention may be useful, for example, to
create a channel within a graft composed of foreign material. In
some embodiments, the graft is associated with a substantially
tubular supporting structure, for example a stent, located within
an elongated vessel of the body of the patient. In some such
embodiments, the method is performed in order to restore blood flow
to a branch of the elongated vessel being occluded by the graft
material, thus substantially preventing fluid communication between
the branch and the elongated vessel, by creating a channel through
the material.
[0092] With reference now to FIGS. 6A, 6B, 7A and 7B, methods for
in-situ creation of a channel through a stent-graft are
illustrated. In the illustrated embodiments, a stent-graft 606,
composed of a foreign material, has been placed to cover an
aneurysm 604 in an abdominal aorta 600. As shown in these figures,
stent-graft 606 occludes the renal arteries ostia 605.
[0093] This positioning of the stent-graft 606 is typically
necessitated by an inadequate, i.e. too short, proximal neck of the
abdominal aorta 600. One of the greatest challenges of
stent-grafting an abdominal aortic aneurysms 604 is to obtain a
long proximal attachment site to ensure a good seal without
occluding the renal or supra-aortic vessels. If a long proximal
site is unavailable, the ostia of the renal and/or supra-aortic
vessels may become occluded by the stent-graft 606. The present
invention provides a method for creating a transluminal in-situ
channel in order to restore blood flow to any vessels that do
become occluded during the course of such a procedure.
Example 2
[0094] With reference first to FIGS. 6A and 6B, an antegrade
approach to in-situ channel creation is provided. In this approach,
the distal end region 104 is introduced into the body of the
patient through the body vasculature inside the thoracic cavity, or
in other words from a position superior to the diaphragm of the
patient, and advanced towards the abdominal aorta 600 in which the
electrode 110 is then positioned. FIG. 6A shows the electrode 110
of the apparatus 100 positioned in the abdominal aorta 600
substantially opposite the renal artery ostium 605, which is
occluded by the stent-graft 606. At this point, energy may be
delivered from an energy source through the electrode 110 in order
to create a channel 608, as seen in FIG. 6B, in or through the
stent-graft 606. FIG. 6B shows the electrode 110 after it has been
advanced through the channel 608 into the renal artery 602.
Creation of the channel allows for fluid communication and
restoration of blood flow between the abdominal aorta 600 and the
renal artery 602. At this point, as described above with respect to
FIG. 4, the channel 608 may be dilated using one or more of a
dilator and a balloon (for example a cutting balloon) and a stent
may be placed across the channel 608 to maintain the patency of the
renal artery 602.
[0095] With reference now to FIGS. 7A and 7B, a retrograde approach
is illustrated. In this approach, introducing the distal end region
104 into the body of the patient includes introducing the distal
end region into the body vasculature and through the renal artery
602 towards the abdominal aorta 600. In such an embodiment,
positioning the electrode 110 substantially adjacent to a material
first surface then includes positioning the electrode 110
substantially adjacent to the renal artery ostium 605 outside of
the abdominal aorta 600.
[0096] With reference first to FIG. 7A, the electrode 110 of the
apparatus 100 is positioned in the renal artery 602 at the renal
artery ostium 605, which is occluded by the stent-graft 606. At
this point, energy may be delivered from an energy source through
the electrode 110 in order to create a channel 608 in or through
the stent-graft 606. FIG. 7B shows the electrode 110 after it has
been advanced through the channel 608 into the abdominal aorta 600.
As mentioned hereinabove, creation of the channel 608 may allow for
fluid communication and the restoration of blood flow between the
abdominal aorta 600 and the renal artery 602. At this point, as
described above with respect to FIG. 4, the channel 608 may be
dilated using one or more of a dilator and a balloon (for example a
cutting balloon) and a stent may be placed across the channel to
maintain the potency of the renal artery. It should be noted that
in the embodiment of FIGS. 7A and 7B, step 404 of the method
comprises obtaining access to renal artery 602, for example during
a surgical procedure or via a deep puncture.
[0097] It should be noted that, although this example has been
described in conjunction with treatment of an abdominal aortic
aneurysm, a similar method is also contemplated for treating a
thoracic aortic aneurysm, whereby a subclavian artery, for example,
may become occluded by a stent-graft. Such a condition may be more
easily treated using a retrograde approach, by inserting an
apparatus through the subclavian artery towards the aorta. In
addition, vessels other than the renal arteries 602 may be occluded
by an abdominal aortic stent-graft, for example the mesenteric
arteries (not shown in the drawings). Alternatively, similar
embodiments of the method may be practiced in other situations
whereby a vessel ostium (or any portion of an elongated vessel,
tube and/or duct) in a patient's body is occluded by a foreign
material.
Example 3
[0098] With reference now to FIGS. 8A-8D, alternate methods for
in-situ creation of a channel through a stent-graft are
illustrated. In the illustrated embodiments, a stent-graft 806,
composed of a foreign material, has been placed to cover an
aneurysm 804 in a section of the descending aorta, more
specifically, within the thoracic aorta 800. As shown in these
figures, the stent-graft 806 occludes the opening or ostium 805 of
the Left Subclavian Artery (LSA) 802.
[0099] In the illustrated example, the positioning of the
stent-graft 806 at the LSA ostium 805 is necessitated by the
proximity of the LSA ostium 805 to the site of the aneurysm 804. A
challenge is generally presented when an aneurysm 804 occurs within
a vessel near an ostium of a side branch vessel, such as the LSA
802. It may become difficult to place the stent-graft 806 within
the vessel to ensure protection of the aneurysm 804 while
maintaining patency of the side branch ostium. In one such example,
the aneurysm 804 and the LSA ostium 805 are located substantially
adjacent each other. "Adjacent" may be taken to mean next to, in
proximity to, near to, or in the vicinity of. In one example the
aneurysm 804 and the LSA ostium 805 are located opposite to one
another along the coronal and/or saggital planes. In other words,
the aneurysm 804 and the LSA ostium 805 are radially opposed to one
another. In a further example, the aneurysm 804 and the ostium 805
may be positioned axially adjacent to one another. In other words,
the aneurysm 804 and the LSA ostium 805 may be positioned
substantially collinearly with respect to each other. Thus, the
proximity of the aneurysm 804 to the LSA ostium may necessitate the
positioning of the stent-graft 806 such that it covers the aneurysm
804 but also occludes the LSA ostium. This positioning of the
stent-graft 806 is typically necessitated by an inadequate, i.e.
too short, proximal neck of the thoracic aorta 800. One of the
greatest challenges of stent-grafting a thoracic aortic anerurysm
804 is to obtain a long proximal attachment site to ensure a good
seal without occluding any of the side branch vessels such as the
Left Subclavian Artery (LSA) 802, the Right Subclavian Artery (RSA)
808', Left Common Carotid Artery (LCCA) 810 or Right Common Carotid
Artery (RCCA) 812. If a long proximal site is unavailable, then an
ostium of a side branch vessel may become occluded by the
stent-graft 806. For the specific case shown in FIGS. 8A-8D, to
treat a thoracic aortic aneurysm, the LSA ostium may become
occluded by the stent-graft 806. This illustrated embodiment of the
present invention provides a method for creating a transluminal
in-situ channel in order to restore blood flow to any vessels that
do become occluded during the course of such a procedure.
[0100] With reference first to FIGS. 8B, and 8C, a retrograde
approach to in-situ channel creation is illustrated. In this
approach, introducing the distal end region 104 of apparatus 100
into the body of the patient includes introducing the distal end
region 104 into the body vasculature and through the left
subclavian artery (LSA) 802 towards the thoracic aorta 800. In one
specific example, a guide sheath 900 is introduced into the body of
the patient through the body vasculature and advanced into the LSA
via the left brachial artery. The sheath 900 is advanced till a
distal end of the sheath 900 is located about 5 cm from the
stent-graft 806. The apparatus 100 according to an embodiment of
the present invention, along with a guide catheter (not shown), is
then be inserted through the guide sheath 900. The distal end
region 104 of apparatus 100 is then advanced towards the LSA such
that the electrode 110 is positioned adjacent the stent-graft 806
that is occluding the LSA ostium 805. In such an embodiment,
positioning the electrode 110 substantially adjacent to a material
first surface includes positioning the electrode 110 substantially
adjacent to the LSA ostium 805 outside of the thoracic aorta 800.
In some embodiments, a curved guide catheter or a centering
mechanism may be used to direct the apparatus 100 towards the
center of the LSA to position electrode 110 at the desired target
location. In one example, a balloon catheter may be used to centre
the apparatus 100 within the vessel.
[0101] When creating a channel through a stent-graft such as
stent-graft 806, a strut 807 of the stent forming the stent-graft
806 may obstruct advancement of apparatus 100 through the
stent-graft 806. In some embodiments of the present invention, a
guide catheter is used to direct the apparatus 100 around the strut
807, as follows: The guide catheter and apparatus 100 may be
aligned with the stent such that they are positioned against the
strut 807. Gentle buckling of the catheter/apparatus assembly may
be used to confirm that the catheter/apparatus assembly is
positioned against the stent. The guide catheter may be
incrementally adjusted around the strut 807 such that it is
no-longer blocked by the strut 807. In some embodiments, a Right
Anterior Oblique (RAO) view under fluoroscopic imaging may be used
to guide the catheter and the apparatus 100 to the appropriate
position.
[0102] Once the electrode is positioned appropriately, energy is
delivered through the electrode 110 to puncture through the graft
to create a channel 808 there-through. In some embodiments, the
energy may be applied at a voltage of about 400 Vrms, with a duty
cycle of 25 ms ON/975 ms OFF. In one particular example, energy is
applied using the Baylis RFP-200 Generator at a high power setting
for 2 seconds to puncture the graft/fabric of the stent-graft. In
another example, it may be sufficient to deliver energy twice at
durations of 1 second. The apparatus 100 may then be advanced into
the stent-graft 806 under fluoroscopic guidance. In some
embodiments, the energy may be delivered with the power being in
the range of between about 30 Watts to about a 100 Watts; and the
voltage may be in the range of between about 300 Vrms to about 500
Vrms. In some embodiments the energy may be applied for duration of
at least 25 ms. Furthermore, in some embodiment the ON period of
the duty cycle may range from between about 25 ms to about 1000
ms.
[0103] FIG. 8D shows the electrode 110 after it has been advanced
through the channel 808 into the thoracic aorta 800. As mentioned
hereinabove, creation of the channel 808 may allow for fluid
communication and the restoration of blood flow between the
thoracic aorta 800 and the LSA 802. At this point, as described
above with respect to FIG. 4, the channel 808 may be dilated using
one or more of a dilator and a balloon (for example a cutting
balloon) and a stent may be placed across the channel to maintain
the patency of the LSA. It should be noted that in the embodiment
of FIGS. 8B and 8C, step 404 of the method comprises obtaining
access to LSA 802, for example during a surgical procedure or via a
deep puncture.
[0104] An additional challenge that may be faced when creating a
channel through a stent-graft using radiofrequency energy is
contact of the energized electrode with a strut, for example strut
807, of the stent-graft 806. Embodiments of the present invention
provide a method for indicating a metal contact error if the
electrode 110 of the apparatus 100 is in contact with the strut
807. In accordance with such embodiments, the energy delivery
system prevents delivery of energy when the electrode 110 is
positioned adjacent to or in contact with the metallic strut 807
but allows the apparatus 100 to delivery energy near the
electrically conductive strut 807 of the stent-graft 806. This
allows the physician to continue to deliver energy from the
electrode 110 and steer the electrode 110 away from the strut 807.
Thus, the orientation or position of the electrode 110 may be
re-adjusted by moving it around or away from the metal strut 807,
while power is being delivered. This allows the user to deliver
energy from electrode 110 while it is positioned close to the
metallic strut 807, allowing electrode 110 to cut through the
stent-graft 806, but generating a "metal detect" error if the
electrode 110 is in contact with the metallic strut 807 or close
enough to produce undesired arcing.
[0105] With reference first to FIGS. 9A and 9B, an antegrade
approach to in-situ channel creation is provided. In this approach,
the distal end region 104 is introduced into the body of the
patient through the body vasculature and advanced towards the
thoracic aorta 800 in which the electrode 110 is then positioned.
In one specific example, femoral access is used to guide the distal
end region 104 of the apparatus 100 into the lumen of the
stent-graft 806 that is positioned within the thoracic aorta. FIG.
9A shows the electrode 110 of the apparatus 100 positioned in the
thoracic aorta 800 substantially opposite the left subclavian
artery (LSA) ostium 805, which is occluded by the stent-graft 806.
At this point, energy may be delivered from an energy source
through the electrode 110 in order to create a channel 808, as seen
in FIG. 9B, in or through the stent-graft 806. FIG. 9B shows the
electrode 110 after it has been advanced through the channel 808
into the left subclavian artery (LSA) 802. Creation of the channel
allows for fluid communication and restoration of blood flow
between the thoracic aorta 800 and the LSA 802. At this point, as
described above with respect to FIG. 4, the channel 808 may be
dilated using one or more of a dilator and a balloon (for example a
cutting balloon) and a stent may be placed across the channel 808
to maintain the patency of the LSA 802.
[0106] FIG. 10 is a flow chart illustrating an example of such a
method. As shown by step 1004, an energy delivery device such as
apparatus 100 may be positioned within a region of tissue at a
target location within a patient's body. At step 1006, an RF power
source may be used to supply RF energy to the apparatus 100. An
energy delivery parameter, for example the current output from the
ground return pathway of the apparatus 100, is monitored. The
measured values of the current are compared to a predetermined
current range or magnitude threshold.
[0107] At step 1008, the measured current is analyzed to determine
if it is greater than the predetermined threshold or range. If the
current has peak currents that exceed the current magnitude
threshold or normal operational currents, at step 1010 an excess
current or over-current is recorded. If the monitored current is
within the range of normal operational currents (below the
predetermined current threshold), then the delivery of energy
through the energy delivery device will not be interrupted and
energy delivery can continue at step 906 and the current can
continue to be monitored. At step 1012, a determination is made to
assess whether or not the extent of over-currents recorded within a
time period is greater than a predetermined sensitivity threshold
and, if it is, then the energy delivery may be adjusted at step
1014. In one example, adjustment of the energy delivery comprises
stopping the delivery of energy. In some embodiments, the extent of
over-currents recorded may be determined in terms of the sum or
magnitude of the over-currents recorded. In other embodiments, the
extent of over-currents recorded may be determined in terms of the
number or quantity of over-currents recorded. If the extent of
over-currents is below the sensitivity threshold, then at step 1006
the energy delivery is continued while monitoring the current. Such
a method as described above can thereby be utilized to prevent
delivery of energy to the electrode when it would be detrimental to
the patient to do so, for example when the electrode is positioned
too close to a strut of the stent graft. Further details regarding
the generation of a "metal detect" error as described hereinabove
are found in U.S. provisional application No. 61/448,578,
previously incorporated herein by reference.
[0108] A method for transluminal in-situ channel formation, for
example as described herein, allows for more accurate placement of
the channel, less reliance on preoperative imaging, increased
availability and decreased cost of a "universal", non-customized
graft, and eventually, more accessibility for a greater number of
patients to the advantages of endovascular repair. As well, the
technique could be used as a `salvage` procedure when inadvertent
coverage of side branches occurs. Most importantly, it would allow
more accurate placement of the channels with the stent-graft in
place in the aorta, rather than based on preoperative radiographic
imaging.
[0109] The methods of the present invention provide a surprising
and unexpected result in that energy, for example radiofrequency
electrical energy is usable to create a channel in foreign material
within the body of the patient, including, for example, synthetic
material substantially not composed of cellular-based biological
tissue (although it may, in some embodiments, be covered with live
cells if, for example, it has been implanted in the body for a
sufficient amount of time). In addition, embodiments of the present
invention may minimize the risk of accidental puncture or
perforation of a blood vessel or other bodily structure.
Furthermore, embodiments of the present invention provide for the
creation of a channel without requiring a mechanical tear of the
foreign material. The methods of the present invention may also be
useful in other applications, including, in general, wherever
foreign material in a patient's body should be penetrated.
[0110] In accordance with one broad aspect, embodiments of the
present invention provide a method for creating a channel through a
foreign material located in a body of a patient, said foreign
material defining a material first surface and a substantially
opposed material second surface, said channel extending through
said foreign material between said material first and second
surfaces, said method using an apparatus including an electrode,
said method comprising: positioning said electrode substantially
adjacent to said material first surface; energizing said electrode
with a radiofrequency current; and using said electrode energized
with said radiofrequency current to deliver energy into said
foreign material to create said channel; wherein said body includes
a heart defining a septum, said septum comprising an aperture
extending there-through and wherein said foreign material extends
across the aperture to cover the aperture.
[0111] In accordance with another broad aspect, some embodiments of
the present invention provide a method of gaining access into a
left side of a heart, the heart having a septum defining an
aperture, wherein foreign material extends across the aperture,
said method using an apparatus including an electrode, said method
comprising: positioning said electrode substantially adjacent to
said foreign material; and creating a channel within said foreign
material using said electrode energized with said radiofrequency
current to deliver energy into said foreign material to allow the
apparatus to be advanced through the channel thereby crossing the
septum to be positioned into the left side of the heart.
[0112] In accordance with another broad aspect, some embodiments of
the present invention provide a method for creating a channel
through a foreign material located in a body of a patient, said
foreign material defining a material first surface and a
substantially opposed material second surface, said channel
extending through said foreign material between said material first
and second surfaces, said method using an apparatus including an
electrode, said method comprising: positioning said electrode
substantially adjacent to said material first surface; energizing
said electrode with a radiofrequency current; using said electrode
energized with said radiofrequency current to deliver energy into
said foreign material to create said channel; assessing a
composition of a material in contact with said apparatus; and upon
determining that said electrode is positioned adjacent a metallic
structure, repositioning the apparatus away from said metallic
structure.
[0113] Many other methods and particular applications may be used
with an apparatus of the present invention, and some embodiments of
the method of the present invention may be used with an apparatus
other than that specifically described in the "APPARATUS" section
of this application.
[0114] It is appreciated that certain features of the invention,
which are, for clarity, described in the context of separate
embodiments, may also be provided in combination in a single
embodiment. Conversely, various features of the invention, which
are, for brevity, described in the context of a single embodiment,
may also be provided separately or in any suitable
subcombination.
[0115] Although the present invention has been described
hereinabove by way of preferred embodiments thereof, it can be
modified, without departing from the scope and nature of the
subject invention as defined in the appended claims.
* * * * *